Effects of Blood Letting on Insulin Sensitivity and Blood Pressure in Patients With Metabolic Syndrome: A Randomized Controlled Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- insulin sensitivity
研究概览
简要总结
Metabolic syndrome (MS) has an increasing prevalence worldwide and there is an urgent need for improvement of medical treatment. In traditional medicine phlebotomy (blood letting) is a recommended treatment for subjects with obesity and vascular disease. Recent studies showed that blood letting with iron depletion may improve insulin sensitivity in patients with diabetes mellitus. The investigators aimed to test if traditional blood letting has beneficial effects in patients with MS. A randomized trial with a sample size of 64 self-referred MS patients was conducted. Patients in the blood letting group were allocated to blood letting intervention and the control group was offered a later treatment (waiting list). In the intervention group 300-400 ml of venous blood were withdrawn at day 1 and after 4 weeks. Primary outcomes were the change of systolic blood pressure and of insulin sensitivity as measured by HOMA-Index.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •25-70 years of age
- •given diagnosis of metabolic syndrome
排除标准
- •clinically significant hepatic, neurological, endocrinologic, or other major systemic or inflammatory disease, including malignancy
- •known history of hemochromatosis, or presence of the Cys282Tyr mutation
- •history of drug or alcohol abuse
- •manifest cardiac disease
- •history of disturbances in iron balance (e.g., hemosiderosis from any cause, atransferrinemia)
- •preexisting anemia
结局指标
主要结局
insulin sensitivity
时间窗: change from baseline at 6 weeks
Glucose and insulin are measured on the basis of overnight fasting blood samples and Insulin sensitivity calculated according to HOMA-Index
systolic blood pressure
时间窗: change from baseline at 6 weeks
Blood pressure is measured twice after 5 minutes rest in the sitting position by sphygmomanometry
次要结局
- pulse rate(change from baseline at 6 weeks)
- diastolic blood pressure(change from baseline at 6 weeks)
- HbA1c(change from baseline at 6 weeks)
- blood lipids(change from baseline at 6 weeks)
- serum ferritin(change from baseline at 6 weeks)
- adiponectin(change from baseline at 6 weeks)
- blood count(change from baseline at 6 weeks)
- serum iron(change from baseline at 6 weeks)
- hs-CRP(change from baseline at 6 weeks)
- serum glucose(change from baseline at 6 weeks)
研究者
Andreas Michalsen
Professor of Medicine
Charite University, Berlin, Germany